FDA UDI
In Commercial Distribution
🇺🇸 United States
Aeris Balloon Dilation Catheter
DI: KG0830
·
Model: KG0830
·
BRYAN MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Aeris Balloon Dilation Catheter
- Primary DI
- KG0830
- Version / Model
- KG0830
- Company Name
- BRYAN MEDICAL, INC.
- Labeler DUNS
- 160067273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-18
- Public Version
- 1
- Public Version Date
- 2020-12-28
- Public Version Status
- New
- Public Device Record Key
- 86ca52ad-ae30-4f43-a7c5-602396ea0cce
Device Description
Aeris Balloon Dilation Catheter 8x30mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17827 | Bronchial balloon catheter | A sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | KG0830 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150951 | 000 |